Kornimate/medical-research-clean huggingface dataset:
cognitive training for diabetes self-management

Conditions: Diabetes Mellitus, Type 2

Summary: the overall objective of this study is to determine the effects of a comprehensive cognitive rehabilitation intervention on biological, cognitive, and diabetes self-management outcomes.

aim 1: test the efficacy of the mapss-dm intervention for improving cognitive function, a1c, and dm-sm. based on preliminary data, the working hypothesis is that compared with the control group, persons who receive the intervention will have improved memory, executive function, and perceived cognitive function, greater use of cognitive strategies, and improved dm-sm immediately post-intervention and at three and six-months post-intervention. aim 2: to explore changes in glycemic variability and their association with changes in cognitive function. the working hypothesis here is that mapss-dm participants will exhibit less glycemic variability post-intervention as compared with baseline and glycemic variability will mediate improvements in cognitive test performance.

Eligibility criteria:
inclusion criteria: * age 50 years old or greater * t2dm diagnosis for 2 years * access to phone and internet * score of ≥10 on the perceived deficits questionnaire (pdq) * a1c of \>7%. exclusion criteria: * a diagnosis of dementia/head injury * score of \>5 on the mini-cog * inability to speak english, and t1dm diagnosis

Keywords: cognitive function glucose variability
abilify in bipolar disorder for 24 weeks treatment effectiveness

Conditions: Bipolar Disorder

Summary: to demonstrate the difference between abilify with depakote vs. placebo with depakote in 24-week treatment in patients with remission status after abilify with depakote in the 6-week study of acute mania in patients with bipolar disorder

further study details as provided by korea oiaa

Eligibility criteria:
inclusion criteria: 1. mania or mixed episode of bipolar disorder according to dsm-iv 2. male and female between the age of 18 and 65 (in case of child-bearing women, negative pregnancy test results should be confirmed before the administration of the investigational drug and appropriate contraception be used. pregnant and breast-feeding women cannot be included) 3. patients who can consent to participate in this clinical trial 4. patients who understand this trial and comply with all protocol requirements 5. patients who fulfill the following remission criteria for bipolar disorder in the two consecutive evaluation performed every week at week 6 of 6-week study and thereafter: (definition of remission: a score less than 12 on the ymrs total score and simultaneously a score less than 13 on the madrs total score) exclusion criteria: 1. patients with the following clinical symptoms diagnosed using dsm-1. patients with the following clinical symptoms diagnosed using dsm-iv: * delirium, dementia, amnestic or other cognitive disorders * schizophrenia or schizoaffective disorder 2. patients who do not respond to clozapine 3. patients who are expected to require the administration of prohibited concomitant drugs during the clinical trial period 4. patients diagnosed with substance-related disorder according to dsm-iv within the past 3 months (abuse, intoxication, dependency and/or withdrawal symptoms). the abuse of benzodiazepines is included with the exception of caffeine or nicotine. 5. patients known to have allergy or hypersensitivity reaction to abilify(aripiprazole) or other quinolinones 6. patients at high risk of suicide attempt or with the history of murder or mental status test 7. patients with the history of neuroleptic malignant syndrome 8. patients with the past history which may cause serious adverse events that can affect the safety or efficacy evaluation during the clinical trial period 9. patients with clinically significantly abnormal laboratory results, vital sign or ecg results 10. pregnant women or child-bearing women who do not or cannot use appropriate contraception 11. patients with the history of convulsive disorder 12. patients judged to have decreased compliance to the investigational drugs during a 6-week trial period by an investigator 13. patients who commit serious protocol violation during a 6-week trial
reach: rwe retrospective study to evaluate cenobamate impact on health care resource utilization

Conditions: Epilepsy With Uncontrolled Focal-onset Seizures

Summary: the study is an observational, retrospective study which aim is to assess cenobamate's healthcare resources utilization (hcru) in the management of uncontrolled focal onset seizures. the amin objective is to compare the resource utilization before and after the use of cenobamate. data from medical charts will be used and inserted into the ecrf from which the analyses will be conducted. data from 200 patients from 10 sites in 5 countries are included.


Eligibility criteria:
inclusion criteria: 1. male and female patients of any ethnic origin ≥18 years old at index date; 2. patients with a diagnosis of epilepsy with uncontrolled focal-onset seizures despite the previous treatment with from 2 to 5 asms who started treatment with cenobamate at index date; 3. patients presenting at least 1 seizure a month in the last 6 months prior to index date; 4. patients with at least 6 months of data coverage in the medical records prior to the index date; 5. patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months). 6. patients who give the consent to the processing of personal data according to the general data protection regulation (gdpr) and/or other applicable local regulation. exclusion criteria: 1. patients who meet any of the contraindications to the administration of adjunctive asms according to their approved smpc; 2. patients who started cenobamate within an eap; 3. progressive neurological disease, including degenerative cns diseases and/or progressive brain tumors; 4. patients with specific syndrome (e.g. lgs and dravet); 5. pregnancy or lactation; 6. patients without self-judgement ability; 7. patients with substance and alcohol abuse or dependence (except for caffeine and nicotine); 8. patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.

Keywords: anti-seizure medications epilepsy
impact of patient position on the success in placing triple-cuffed double lumen endotracheal tube

Conditions: Lung Diseases

Summary: triple-cuffed double lumen endotracheal tube (tc-dlt, ankor tube. insung corp., korea) which was developed to isolate lung without endotracheal bronchoscope guidance has additional carinal cuff placed between bronchial tube cuff and tracheal tube cuff. this device has been successfully used to isolate lung more simply in specific settings when there is too much excretion to visualize endotracheal structure or for a health provider who is not good at use of traditional double-lumen tube. although tc-dlt is designed to enable lung separation effectively in situations that confirmation of tube position using bronchoscopy is difficult or not available, but no studies have been conducted on whether effective lung isolation using tc-dlt is possible after change in the relative position of the bronchial tree by postural change. this plan was prepared for research on this.

after enter into operating room, induction of anesthesia is performed through standard general anesthesia procedure before endotracheal intubation. endotracheal intubation is performed using tc-dlt and inflate carinal cuff with 5 \~ 15ml of air. then, push it into trachea until resistance is felt. when carinal cuff is placed at carina, deflate carinal cuff and isolate independent lung followed by confirmation of bronchial cuff position using fiberoptic bronchoscopy. record the location of the bronchial balloon in one of the following conditions 1. at proper position(proximal upper end of bronchial balloon is between 5mm from carinal opening) : 2. proximal end of bronchial balloon is placed more of 5mm distally from carinal opening 3. proximal end of bronchial balloon is placed more of 5mm proximally from carinal opening then, change patient position to left lateral decubitus (lld) position and check the position of bronchial balloon using fiberoptic bronchoscopy as previously done. 1. at proper position(proximal upper end of bronchial balloon is between 5mm from carinal opening) : 2. proximal end of bronchial balloon is placed more of 5mm distally from carinal opening 3. proximal end of bronchial balloon is placed more of 5mm proximally from carinal opening after check whether there is something to considerate, end this case.

Eligibility criteria:
inclusion criteria: * adults who is including in asa class i or ii * patients scheduled for right lung surgery under right lung isolation * patients who don't have any anatomical variations in pulmonary system * patients who have never gotten a lung surgery exclusion criteria: * pregnancy * patients who are predicted difficult intubation * patients who is under upper airway infection * patients who have coagulopathy * emergency surgery * in addition, patients considered inappropriate to participate in this study

Keywords: 3-cuffed double lumen tube one lung ventilation lung isolation
a study of continued treatment among participants who have responded to peginterferon alfa-2a (pegasys®) or recombinant interferon alfa-2a (roferon-a®) in prior clinical studies

Conditions: Chronic Myelogenous Leukemia; Malignant Melanoma; Renal Cell Carcinoma

Summary: this open label extension study will give an opportunity to the participants that have responded to the treatment with pegylated-interferon alfa-2a (pegasys) or recombinant interferon alfa-2a (roferon-a®) in prior clinical studies no15753 (nct00003542) for renal cell carcinoma (rcc), no15764 (nct number not available) and no16006 (nct02736721) for chronic myelogenous leukemia (cml), and no16007 (nct number not available) for malignant melanoma (mm).


Eligibility criteria:
inclusion criteria: * participants must have completed protocol no15753, no15764, no16006 or no16007 and responded to treatment at the end of the trial as defined in the parent protocol * cml participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. mm and rcc participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study exclusion criteria: * pregnant or lactating women * refusal to use adequate contraceptive measures among men and women of childbearing potential
disease burden of pneumonia, meningitis and bacteremia among children in japan: pneumonet japan

Conditions: Pneumococcal Disease

Summary: streptococcus pneumoniae is a major cause of pneumonia, among infants and children in japan and worldwidethis study plans to investigate the rate of invasive pneumococcal disease "ipd " and the rate of hospitalizations due to pneumonia in okinawa and the eastern half of hokkaido currently, only a limited information about pneumococcal disease burden is available in japan.


Eligibility criteria:
eligibility criteria - children residing in the surveillance area(s) aged 28 days to \<60 months with clinical suspicion of pneumonia, meningitis and bacteremia who were admitted to the hospital.

Keywords: pneumonet japan study
a study to evaluate the effects of nst-4016 on qt/corrected qt (qtc) interval

Conditions: Dyslipidemias

Summary: this is a phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo and positive controlled, 4 way crossover study assessing the ecg effects of therapeutic and supratherapeutic doses of icosabutate in healthy male and female subjects.


Eligibility criteria:
inclusion criteria: * 1. males or females, of any race, between 18 and 55 years of age, inclusive, at screening. * 2. body mass index (bmi) between 18.0 and 33.0 kg/m2, inclusive, at screening * 3. in good health exclusion criteria: * 1. an uninterpretable or abnormal ecg at screening and/or check in * 2. history of risk factors for torsades de pointes * 3. sustained supine systolic blood pressure \>140 mmhg or \<90 mmhg * 4. unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia. * 5. female subjects who are pregnant (or planning to become pregnant within 90 days after the final dose administration) or are currently lactating * 6. subjects who, in the opinion of the investigator (or designee), should not participate in this study
bioequivalence study of torrent pharmaceutical ltd.'s of escitalopram oxalate tablets under fed condition

Conditions: Healthy

Summary: objective: primary objective of the present study was to compare the single dose bioavailability of torrent's escitalopram oxalate tablet 20 mg \[test formulation, torrent pharmaceuticals ltd., india\] versus lexapro® (escitalopram oxalate tablet 20 mg) \[reference formulation, forest laboratories inc, usa\] . dosing periods were separated by a washout period during fed study. study design: open-label, randomised, two period, two treatment, crossover, single-dose bioequivalence study


Eligibility criteria:
inclusion criteria: the volunteers were included in the study based on the following criteria: * sex: male. * age: 18 - 45 years. * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. * pulse rate less than 50/minute or more than 100/minute. oral temperature less than 95°p or more than 98.6°p. * respiratory rate less than 12/minute or more than 20/minute * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse * positive breath alcohol test * recent history of kidney or liver dysfunction. * history of consumption of prescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of heart failure. * hiv, hcv, hbsag positive volunteers. * opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. * existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
apoptic biomarkers of periodontal disease

Conditions: Periodontitis

Summary: the goal of this study is to facilitate early diagnosis of gum disease. proteins associated with cell death will be isolated from gum pockets of diseased and healthy patients and evaluated.

early detection of the progression of periodontitis is difficult because it typically relies on comparisons of clinical measurements made with a calibrated probe and nonstandardized radiographs over time. both methods detect periodontal breakdown only after it has occurred. therefore, considerable emphasis has been placed on identifying more specific and sensitive methods to diagnose and detect periodontal disease progression. the overall goal of this project is to determine whether specific apoptosis-associated proteins, specifically fibronectin (fn) fragments, caspase-3, soluble fas, and soluble fas ligand, sampled from gingival crevicular fluid (gcf) can be used as markers for periodontal disease progression.

Eligibility criteria:
inclusion criteria: * adults over age of 18 * healthy or diagnosis of periodontitis exclusion criteria: * active treatment with anti-inflammatory agents such as nsaids or steroids and pregnant females

Keywords: apoptic biomarkers early detection periodontitis gingival crevicular fluid healthy subjects
virtual reality pain neuroscience education for middle school students

Conditions: Pain; Education; Virtual Reality

Summary: investigating the use of a virtual reality (vr) pain neuroscience education (pne) platform with middle school students. the investigators have previously studied the use of pne with in person educational sessions with middle school kids and video recorded sessions. this study will be looking into utilizing the vr platform for delivery of the educational information.

potential middle school students will be contacted through fliers to local parents in the louisville, ky area via various sports team events. the investigators have secured a meeting room space at a large reception room at lake forest country club (louisville, ky) on august 4, 2020. potential participants will call to schedule time for participation to allow for proper staggering of participants arriving on the day of data collection. research team will set up informed consent space at the entrance to the reception room and stagger participant arrival time to reduce contact with other participants. this space will be cleaned and disinfected regularly during the consenting process as new participants arrive. once student and parent arrives they will complete informed consent and covid-19 screening form before being allowed into research space (reception room). each participant will be given a pen to keep during the research study and go home with also provided with hand sanitizer to use before and after. no pens will be reused with other participants. masks will be made available for anyone that requests one, but they will not be required while at the testing location. parents of child will be allowed to sit in waiting chair keeping 6 feet of distance from anyone else. the child research participant will be lead to a chair in the room and complete pre-test questionnaire and then they will be set-up with a virtual reality (vr) device (cleaned and disinfected between each use) and go through a vr educational experience (\~30 minutes) on pain neuroscience education (pne). upon completion of the vr educational session they will complete post-test questionnaire and then be able to leave.

Eligibility criteria:
inclusion criteria: * willing to view vr educational session * in grades 5, 6, 7, or 8. exclusion criteria: * has been through pne educational program previously * aversion to vr or problems with viewing vr in the past * history of epilepsy or seizures * eye surgery or injury within the last 6 months * open sores or wounds around where vr googles are worn on face * anyone who has had a concussion that has not been cleared for full activity or experiencing any post-concussion syndrome symptoms currently.
a multi-omic approach to evaluate and characterize the polycystic ovary syndrome (pcos) phenotype

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this research study is to explore the relationship between the gut microbiome and hormone levels in women diagnosed with pcos and determine whether there are differences in the gut microbiome between women with pcos and women without pcos. consented, enrolled participants will complete a health questionnaire, complete a fasted blood draw at a local laboratory, and provide a stool, saliva, and vaginal swab sample for comprehensive biomarkers, hormones, metagenomics, and metabolomics analysis.


Eligibility criteria:
inclusion criteria: * women diagnosed with pcos or women who are considered healthy * 18-40 years old * residing in the usa, except for exclusion states * have not been using hormonal therapy for at least 3 months exclusion criteria: * women using hormonal therapy within the last 3 months * diagnosed with other significant health conditions or using medications that will affect hormone levels * residing in ny, nj, md, ri, nd, sd, or hi * pregnant or nursing
to evaluate sbi in the dietary management of mild to moderate crohn's disease

Conditions: Crohn's Disease

Summary: the objective of this study is to evaluate the nutritional therapy with sbi (a medical food) as compared to placebo in the clinical dietary management of mild to moderate crohn's disease.

this is a randomized, double-blind, placebo-controlled, multi-center, pilot study evaluating sbi 10 g bid compared to matching placebo for 12 weeks followed by a 12 week open-label extension sbi 10 g bid (enteragam) in the dietary management of mild to moderate crohn's disease. the effect of sbi will be evaluated on crohn's disease related symptoms and inflammation symptom control as measured by crohn's disease activity index (cdai) scores and plasma and stool markers of inflammation. the patient's quality of life will also be assessed as an indicator of disease state.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of mild to moderate crohn's disease for at least 3 months. * screening cdai between \>150 and ≤ 250 based on subject recall. * average of greater than two liquid or soft stools per day and an abdominal pain intensity score \>1. * subject has at least one positive biomarker of inflammation: fecal calprotectin \>100 µg/g; elevated c-reactive protein (crp) \>2 mg/dl. exclusion criteria: * positive stool test for pathogenic bacteria including clostridium difficile or o\&p. * confirmed intestinal stricture with obstructive-like clinical symptoms. * bowel resection within the previous 6 months. * change in medical therapy: must have been on a stable dose of * corticosteroids (prednisone or prednisolone) less than or equal to 20 mg per day for 2 weeks prior to screening, * budesonide less than or equal to 9 mg per day for 2 weeks prior to screening, * 5-aminosalicylates for 2 weeks prior to screening, and * immunomodulators for 6 weeks prior to screening. * taking greater than 20 mg per day of a corticosteroid (prednisone or prednisolone) or greater than 9 mg of budesonide. * received biologic therapy in past 2 years. * diagnosis of one or more co-morbid condition (s) requiring medical or surgical therapy that may affect bowel function, gastrointestinal symptoms. * serious infection in the 3 months prior to enrollment. * allergy or intolerance to beef or to any ingredient used in the product. * participated in an investigational drug or device study within 30 days. * does not have access to the internet. * taken enteragam®

Keywords: ibd inflammatory bowel disease crohn's crohns sbi serum-derived bovine immunoglobulin / protein isolate enteragam